Back to resultsSafety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
SEPIOLA System
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria: calculated CHA2DS2-VASc score of 2 or greater. The subject is non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants. documented non-valvular atrial fibrillation Subject suitable for vascular/cardiac intervention procedure suitable LAA anatomical measurements for study device Exclusion Criteria: Subject who requires anticoagulation for a condition other than AF. NYHA classification IV. Complex congenital heart disease. Presence of circumflex coronary artery stent. The subject has a prosthetic valve in any position. atrial septal defect closure or has an ASD/PFO device. presence of intracardiac thrombus. Any cardiac surgery in the past LVEF < 35%. intracardiac thrombus moderate or severe mitral valve stenosis
Sites / Locations
- Israeli-Georgian Medical Research Clinic HelsicoreRecruiting
- Tbilisi Heart and Vascular ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Implantable device
Arm Description
Endomatic SEPIOLA System
Outcomes
Primary Outcome Measures
SEPIOLA System Safety
Device and Investigational Procedure Related Serious Adverse Events (SAE)
Secondary Outcome Measures
Device success
Confirmation of functional LAA closure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06099106
Brief Title
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
Official Title
Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endomatic Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that cannot take, or have a reason to seek an alternative, to long-term anticoagulation therapy.
Potential patients who are candidates for LAA closure will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure.
All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.
Additional follow up time points are scheduled at 45 days, 6 months and 12 months post procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Implantable device
Arm Type
Experimental
Arm Description
Endomatic SEPIOLA System
Intervention Type
Device
Intervention Name(s)
SEPIOLA System
Intervention Description
Implantation of the SEPIOLA device into the left atrial appendage.
Primary Outcome Measure Information:
Title
SEPIOLA System Safety
Description
Device and Investigational Procedure Related Serious Adverse Events (SAE)
Time Frame
7 days, 45 days and 6 months post procedure
Secondary Outcome Measure Information:
Title
Device success
Description
Confirmation of functional LAA closure
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
calculated CHA2DS2-VASc score of 2 or greater.
The subject is non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants.
documented non-valvular atrial fibrillation
Subject suitable for vascular/cardiac intervention procedure
suitable LAA anatomical measurements for study device
Exclusion Criteria:
Subject who requires anticoagulation for a condition other than AF.
NYHA classification IV.
Complex congenital heart disease.
Presence of circumflex coronary artery stent.
The subject has a prosthetic valve in any position.
atrial septal defect closure or has an ASD/PFO device.
presence of intracardiac thrombus.
Any cardiac surgery in the past
LVEF < 35%.
intracardiac thrombus
moderate or severe mitral valve stenosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boaz Schwarz
Phone
+972 (0)544595839
Email
boaz@endomaticmed.com
Facility Information:
Facility Name
Israeli-Georgian Medical Research Clinic Helsicore
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irakli Gogorishvili, MD
Email
gogorishvili@gmail.com
Facility Name
Tbilisi Heart and Vascular Clinic
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamaz Shaburishvili, MD
Email
tamazshaburishvili@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
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